DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 03/27/26 has been entered in the case. Claims 1-7, 10-12 & 21-22 are pending for examination and claims 13-20 are withdrawn; claims 8-9 are cancelled.
Priority
Examiner acknowledges that the effective filling date for this present application to search is based on provisional application No. 62/866266, filed on 06/25/19.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 10-12 & 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 2018/0015264) in view of Wang (US 2015/0272666).
Regarding claim 1, Wang’264 discloses a method for treating at least one disease (hypertension, pulmonary arteries, diabetes, obesity, heart failure…, see abstract) comprising treating at least two different target tissues in at least two different body lumens (bronchitis airway in Figs. 5A-5B, renal artery in Fig. 5B, gastric artery in Fig. 10A, hepatic plexuses in Fig. 10B, or stomach in Fig. 11), the method comprising:
performing a treatment procedure on a body lumen that is a first body lumen 502 in Fig. 5C, the treatment procedure comprising:
inserting a delivery catheter 106 into the body lumen 502 (extra renal artery, in Fig. 5C), wherein the delivery catheter comprises a catheter shaft 106, a balloon at a distal end portion of the shaft, and an inflation lumen in fluid communication with an interior of the balloon, see Figs. 7-9C for double/triple balloons;
inflating the balloon to center the distal end of the shaft in the body lumen, see Fig. 5C;
denervating or ablating target tissue of the body lumen with the delivery catheter comprising delivering an amount of energy or heat (paras [0050, 0090, 0097, 0133]) to the target tissue effective to injure or damage the target tissue to relieve a disease symptom;
deflating the balloon, (para [0097], By the end of the treatment time, the balloon was deflated and withdrawn, or placed into another artery site if required for the next treatment); and
removing the delivery catheter from the body lumen, (para [0097], By the end of the treatment time, the balloon was deflated and withdrawn, or placed into another artery site if required for the next treatment); and
performing the treatment procedure on a second body lumen, e.g., a main bronchus 21 in Figs. 5A-5B) or a gastric artery 360 in Fig. 10A or hepatic plexuses 345 in Fig. 10B, or stomach in Fig. 11 that different than the first body lumen 502, wherein the first body lumen and the second body lumen belong to different classes of body lumens chosen from renal arteries, gastric arteries, hepatic arteries, pulmonary arteries, celiac arteries, gastroduodenal arteries.
Note: Wang’264 discloses a device and method for treating multiple diseases, i.e., hypertension, pulmonary arteries, diabetes, obesity, heart failure, end-state renal disease... and the treatment in different body lumens, see Figs. 5A, 5C, 10A-11. Wang’264 further states that: after each treatment, balloons were partially deflated and pulled back to a pre-defined distance to avoid overlapping treatment with the next treatment location. Treatment was then repeated, para [0152]; following each treatment, ballons are partially deflated and moved to other locations for additional treatments, para [0155]. Based on the statements above, a person skilled in the art would recognize that the performing the treatment procedure on a second body lumen that different classes of the first body lumen for purpose of treating two or more diseases in a patient.
Wang’264 does not disclose that the energy comprises radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof.
Wang’666 discloses a method of treating at least one disease (hypertension, pulmonary arteries, diabetes, obesity, heart failure…, see abstract) comprising treating at least two different target tissues in at least two different body lumens (bronchitis airway in Figs. 2A-2B, renal artery in Fig. 2C, pulmonary artery, Fig. 4), the method comprising: inserting a delivery catheter into the body lumen; inflating the balloon to center the distal end of the shaft in the body lumen, see Fig. 2A-4;
denervating or ablating target tissue of the body lumen with the delivery catheter comprising delivering an amount of energy (see abstract) to the target tissue effective to injure or damage the target tissue to relieve a disease symptom; wherein the energy comprises radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof, paras [0037, 0051, 0072].
Since Wang’264 and Wang’666 are both from the same field of endeavor, the purpose disclosed by Wang’666 would have been recognized in the pertinent art of Wang’264.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method of Wang’264 with including method of using radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof to injury or damage the tissue/nerve, as taught by Wang’666, in order to have a benefit of symptom relive.
Regarding claim 2, Wang’264 discloses that wherein the first body lumen and the second body lumen belong to different classes of body lumens chosen from renal arteries (Fig. 5C), gastric arteries (Fig. 10A), hepatic arteries (Fig. 10B).
Regarding claim 3, Wang’264 discloses that wherein the at least one disease comprises: at least two diseases; or at least three diseases; or at least four diseases, see the rejection in claim 2 above.
Regarding claim 4, Wang’264 discloses that wherein the disease is chosen from hypertension, pulmonary hypertension, diabetes, obesity, metabolic syndrome, heart failure, myocardial infarction, atherosclerosis, coronary artery disease (CAD), peripheral vascular disease (PAD), end-stage renal disease, digestive disease, nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), urological disease, cancers, tumors, pain, rheumatoid arthritis (RA), asthma, chronic obstructive pulmonary disease (COPD), and a combination thereof, see abstract and para [0014].
Regarding claim 5, Wang’264 discloses that wherein the at least one disease comprises at least two diseases comprising renal hypertension and diabetes, or renal hypertension and obesity, or diabetes and obesity, or a combination thereof, paras [0014-0015, 0024, 0061].
Regarding claim 6, Wang’264 discloses that wherein the relieving the disease symptom comprises reducing blood pressure (hypertension), reducing blood glucose level and A1C, reducing body weight (obesity), reducing restenosis, reducing liver fat, and reducing pain, or a combination thereof, see abstract, paras [0014-0015, 0024, 0061].
Regarding claim 7, Wang’264 discloses that wherein the delivery catheter comprises a chemical infusion delivery catheter, see Figs. 3A-4B, 6-9C; denervating or ablating target tissue of the body lumen with the delivery catheter comprising delivering an amount of formulation (paras [0095, 0097]) to the target tissue.
Regarding claim 10, Wang’264 discloses that wherein the formulation comprises one or more ingredients chosen from water, saline, hypertonic saline, phenol, methanol, ethanol, absolute alcohol, isopropanol, propanol, butanol, isobutanol, ethylene glycol, glycerol, acetic acid, lactic acid, propyl iodide, isopropyl iodide, ethyl iodide, methyl acetate, ethyl acetate, ethyl nitrate. isopropyl acetate, ethyl lactate, lipiodol, urea, and derivatives and combinations thereof, paras [0016-0017].
Regarding claim 11, Wang’264 discloses that wherein the formulation comprises ethanol, paras [0016-0017].
Regarding claim 12, Wang’264 discloses that wherein the formulation comprises an azeotrope, paras [0021-0022].
Regarding claim 21, Wang’264 discloses that wherein the first body lumen or the second body lumen comprises a common hepatic artery 345, see Fig. 10B, and para [0024].
Regarding claim 22, Wang’264 discloses in paras [0152 & 0155] that: after each treatment, balloons were partially deflated and pulled back to a pre-defined distance to avoid overlapping treatment with the next treatment location. Treatment was then repeated; following each treatment, ballons are partially deflated and moved to other locations for additional treatments. Therefore, a person skilled in the art would recognize that the treatment procedure is performed on both the first body lumen and the second body lumen in a single procedure.
Response to Arguments
Applicant's arguments filed 03/27/26 have been fully considered but they are not persuasive.
1) Applicant argues that Wang’264 (or Wang I) describes delivering formulations, e.g., ethanol to target tissues. Applicant further states that: Wang’264 does not describe delivering radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Wang’264 states that: amounts of the formulation and/or energy are effective to injure or damage tissue, nerves, and nerve endings in order to relieve disease symptoms, see abstract; the energy or heat can enhance the injury/damage/elimination effect by accelerating the reaction rate between the formulation and tissues, para [0050]. Wang’264 further states that using the catheter to infuse the formulation and/or heat to the tissue of the body lumen adjacent to the nerves, paras [0141-0148]. Although Wang’264 does not specifically to mention of using what kinds of energy such as: RF energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy. It is well-known in the art to recognize that the method of using different kind of energies listed above that related to the energy and/or heat to damage, injure tissue, nerve. Similarly, Wang’666 teaches that the amounts of formulations and/or energy are effective to injury or damage the tissues to have a benefit of symptom relive.
The energy can be radiofrequency, cryoablation, microwave, laser, ultrasound, and/or high-intensity focused ultrasound energies... , see para [0037].
Giving such a teaching by Wang’666, a person having ordinary skill in the art would have easily recognizes that modifying the method of Wang’264 with providing a method of using energy such as radio frequency, cryoablation, microwave, laser, ultrasound, and/or high-intensity focused ultrasound energies, as taught by Wang’266, in order to have a benefit of symptom relive.
2) Applicant argues that Wang’264 does not describe or suggest a method in which the same energy-based procedure is performed sequentially on body lumens from different classes.
Wang’264 clearly shows in different figures 55A-5C, 10A-11 that a method of using energy-based procedure is performed on body lumens from different classes, i.e., bronchial tree; extra renal artery, gastric artery, hepatic plexuses, duodenum. Wang further states in para [0152] that: after each treatment, balloons were partially deflated and pulled back to a pre-defined distance to avoid overlapping treatment with the next treatment location. Treatment was then repeated; In para [0155] states that: following each treatment, ballons are partially deflated and moved to other locations for additional treatments.
Since Wang’264 can be used the method of using energy-based procedure in different body lumens from different classes, a person skilled in the art would recognize that the method can be performed sequentially on different body lumens (e.g., moved to other locations for additional treatments, as mentioned in para [0155]) for treating same person who having multiple symptoms, i.e., hypertension, diabetes, obesity, heart failure...
3) Applicant argues that the combination requires impermissible hindsight
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this case, Wang’264 discloses a method of delivering an amount of energy to the target tissue effective to injure or damage the target tissue to relieve a disease symptom, see abstract, & paras [0141-0148]. Although Wang’264 does not mention what kind of energy to injure or damage the target tissue. On the other hand, Wang’666 discloses a method of treating multiple diseases (same as multiple diseases as discussed in Wang’264) such as hypertension, pulmonary arteries, diabetes, obesity, heart failure…, see abstract). Wang’666 compensates the missing of using multiple kind of energies, i.e. radiofrequency energy, microwave energy, laser energy, ultrasound energy, high-intensity focused ultrasound energy or a combination thereof, for denervating or ablating target issue in order to relieve diseases symptoms, paras [0037, 0051, 0072]. Since Wang’264 and Wang’666 are both from the same field of endeavor, the purpose disclosed by Wang’666 would have been recognized in the pertinent art of Wang’264. Therefore, the combination of Wang’264 in view of Wan’666 is proper and valid.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached M-F 7:30 am-4:00 pm.
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/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783
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